Merck (NYSE:MRK), known as MSD outside of the United States and Canada, announced that KEYTRUDA® (pembrolizumab for injection), Merck's anti-PD-1 therapy, in combination with enfortumab vedotin, an antibody-drug conjugate (ADC), is approved by Health Canada as neoadjuvant treatment and then continued after radical cystectomy (RC) as adjuvant treatment, for adults with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy.

This approval is based on results from the pivotal Phase 3 KEYNOTE-905 trial (also known as EV-303), which was conducted in collaboration with Pfizer and Astellas. The trial demonstrated a statistically significant improvement in EFS and OS in patients treated with neoadjuvant and adjuvant KEYTRUDA in combination with enfortumab vedotin compared with RC and PLND alone. It also demonstrated a statistically significant difference in pCR rate.